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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018680
Receipt No. R000021575
Scientific Title Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Date of disclosure of the study information 2015/08/17
Last modified on 2017/06/22

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Basic information
Public title Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Acronym Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Scientific Title Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Scientific Title:Acronym Clinical study of breast reconstruction by multistep cell-assisted lipotransfer (Step-CAL) method with cultivated autologous adipose-derived stromal stem cells (ASC) after mastectomy for breast cancer
Region
Japan

Condition
Condition Breast reconstruction after mastectomy for breast cancer
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the safety of the breast reconstruction by Step-CAL method using cultivated autologous adipose-derived stromal stem cells after mastectomy for breast cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Every adverse event occurred in the period from the first liposuction to the last observation day will be assessed by the relation with the treatment, incidence rate, severity, and seriousness.
Key secondary outcomes (1)volume (rate of engraftment): change in the period from enrollment to 6 months after the last lipoinjection
(2) projection (rate of restoration): change in the period from the enrollment to 6 months after the last lipoinjection
(3) evaluation of cells: evaluation of cultivation process and cultivated cells
(4) questionnaire to the subjects
(5) rate of completion of the treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 (1) Placement and removal of tissue expander (TE)
For breast reconstruction, TE will be placed in the target breast in the first operation and removed in the fourth operation.

(2) Liposuction
In the first, the second, and the third operations with intervals of 4 to 6 months, fat will be aspirated from abdomen, buttocks, or thighs of patient. The fat will be used for injection into the breast and for preparation of ASC. The ASC prepared from approximately 20 ml of fat will be cultivated and cryopreserved for the next operation.

(3) Lipoinjection
In the second, the third, and the fourth operations, the aspirated fat will be mixed with the cryopreserved ASC and injected into the breast. In each operation, the TE will be taken out from the breast before fat injection and the volume of the TE will be reduced appropriately. After fat injection, the TE will be placed into the breast again.



Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria (1) Woman underwent mastectomy in a breast for breast cancer of 0-II TNM classification
(2) Age 20 years or more, and 60 years or less
(3)Patient signed the consent form of this study
Key exclusion criteria (1) Patient underwent tissue expander placement in the breast after the mastectomy
(2) Any gross distortion derived from endogenous or exogenous cause is seen in the healthy breast
(3) Patient underwent the mastectomy within a year
(4) Patient has any cancer or history of cancer except the breast cancer within 5 years
(5) Body Mass Index (BMI) less than 18
(6) Patient is or may be infected with hepatitis B, hepatitis C, HIV, HTLV, or parvovirus B19
(7) Patient has severe allergy to any substances including antibiotics or bovine serum components
(8) Patient has any of the following complications: (a) autoimmune disease (b) uncontrollable ischemic heart disease, diabetes mellitus, or mental disorder
(9) Patient is enrolled or has been enrolled into any other clinical study within 6 months
(10) Patient is or may be pregnant
(11) Patient has been judged not to be eligible for the study subject by the attending physician
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Tsuji
Organization Cellport Clinic YOKOHAMA
Division name President
Zip code
Address Yokohama Excellent III 2F, 3-35, Minaminakadori, Naka-ku, Yokohama, 231-0006, Japan
TEL 045-222-3338
Email tsuji@cellport.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidaka Urano
Organization Biomaster, Inc.
Division name Administration division
Zip code
Address Yokohama Excellent III 2F, 3-35, Minaminakadori, Naka-ku, Yokohama, 231-0006, Japan
TEL 045-222-3363
Homepage URL
Email urano@biomaster.jp

Sponsor
Institute Cellport Clinic YOKOHAMA
Institute
Department

Funding Source
Organization Biomaster, Inc.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 PB3150003
Org. issuing International ID_1 Ministry of Health, Labor and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2017 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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